Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 12483-12484 [2021-04371]

Download as PDF Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices jbell on DSKJLSW7X2PROD with NOTICES Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500, or at https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, (ELEM–4029) Division of Enforcement, Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240–402–8743, or at debarments@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act. On June 18, 2020, Mr. Ryan was convicted as defined in section 306(l)(1) of the FD&C Act when judgment was entered against him in the U.S. District Court for the Eastern District of Virginia, Norfolk Division, after his plea of guilty to one count of conspiracy to defraud the United States in violation of 18 U.S.C. 371. The factual basis for this conviction is as follows: As contained in the Statement of Facts in Mr. Ryan’s case, filed on January 8, 2020, from October 2007, and continuing through September 2010, Mr. Ryan, a physician, authorized drug orders for RX Limited (also known as RX Partners), an internet pharmacy organization that facilitated the unlawful distribution of prescription drugs to consumers throughout the United States. RX Limited had a business model whereby it allowed consumers to fill out a brief medical questionnaire, select the type of drugs the consumer desired, the desired drug strength, and the desired drug quantity and pay by credit card. RX Limited then forwarded the order to a participating physician for ‘‘approval.’’ The drugs sold by RX Limited were dispensed without a valid prescription because there was no valid doctor-patient relationship established between the authorizing physicians and the customers. Customers had no face-toface contact with the participating physician and were not subject to any mental or physical examinations. The physicians authorizing the orders for prescription drugs sold by RX Limited did not take patient histories or perform any diagnostic or laboratory testing, did not check the accuracy of the information customers provided VerDate Sep<11>2014 17:29 Mar 02, 2021 Jkt 253001 (including their identities, ages, and qualifying medical conditions), and did not monitor, or provide any means to monitor, medication response. After the participating physician authorized the prescription, RX Limited sent the order to a fulfillment pharmacy, which fulfilled the order and mailed the drugs to the customer. As a participating physician, Mr. Ryan authorized more than 158,000 drug orders for well over 10 individual RX Limited customers. Prescription drugs distributed pursuant to these orders included, FIORICET (and its generic equivalents), Carisoprodol (SOMA), Tramadol (ULTRAM), VIAGRA, CIALIS, and XENICAL. RX Limited paid Mr. Ryan $2.00 per drug order he authorized. From October 2007 through September 2010, RX Limited paid Mr. Ryan at least $316,153 for the orders he authorized. As a result of this conviction, FDA sent Mr. Ryan by certified mail on September 11, 2020, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Ryan was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. The proposal also offered Mr. Ryan an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted an election not to use the opportunity for a hearing and a waiver of any contentions concerning this action. Mr. Ryan received the proposal on September 18, 2020. Mr. Ryan did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Ryan, has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of a drug product under the FD&C Act. As a result of the foregoing finding, Mr. Ryan, is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, effective (see DATES) (see sections 306(a)(2)(B) and PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 12483 (c)(2)(A)(ii) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of, Mr. Ryan, in any capacity during his debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Ryan provides services in any capacity to a person with an approved or pending drug product application during his period of debarment, he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug application from Mr. Ryan during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B)). Note that, for purposes of section 306 of the FD&C Act, a ‘‘drug product’’ is defined as a drug subject to regulation under section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382) or under section 351 of the Public Health Service Act (42 U.S.C. 262) (see section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))). Any application by Mr. Ryan for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA–2020–N–1638 and sent to the Dockets Management Staff (see ADDRESSES). The public availability of information in these submissions is governed by 21 CFR 10.20. Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. Dated: February 25, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–04375 Filed 3–2–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0008] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a SUMMARY: E:\FR\FM\03MRN1.SGM 03MRN1 12484 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will take place virtually on April 6, 2021, from 9 a.m. Eastern Time to 6 p.m. Eastern Time. ADDRESSES: Please note that due to the impact of this COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: https://www.fda.gov/ advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings. jbell on DSKJLSW7X2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993–0002, aden.asefa@ fda.hhs.gov, 301–796–0400, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On April 6, 2021, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc. The proposed Indication for Use for the TransMedics OCS Heart, is as follows: The TransMedics Organ Care System (OCS) Heart System is a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts in a nearphysiologic, normothermic, and beating VerDate Sep<11>2014 17:29 Mar 02, 2021 Jkt 253001 state intended for a potential transplant recipient. OCS Heart is indicated for donor hearts with one or more of the following characteristics: • Expected cross-clamp or ischemic time ≥4 hours due to donor or recipient characteristics (e.g., donor- recipient geographical distance, expected recipient surgical time); or • Expected total cross-clamp time of ≥2 hours PLUS one of the following risk factors: • Donor Age ≥55 years; or • Donors with history of cardiac arrest and downtime ≥20 minutes; or • Donor history of alcoholism; or • Donor history of diabetes; or • Donor Left Ventricular Ejection Fraction ≤50 percent but ≥40 percent; or • Donor history of Left Ventricular Hypertrophy (septal or posterior wall thickness of >12 and ≤16 mm); or • Donor angiogram with luminal irregularities but no significant coronary artery disease. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/ advisory-committees/circulatory-systemdevices-panel/2021-meeting-materialscirculatory-system-devices-panel. Select the link for the 2021 Meeting Materials. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 30, 2021. Oral presentations from the public will be scheduled on April 6, 2021, between approximately 1 p.m. Eastern Time and 2 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). The notification should include a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 an indication of the approximate time requested to make their presentation on or before March 22, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 23, 2021. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallet at Artair.Mallet@fda.hhs.gov or 301– 796–9638 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/advisorycommittees/about-advisory-committees/ public-conduct-during-fda-advisorycommittee-meetings for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 25, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–04371 Filed 3–2–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1411] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and Drug Administration Regulated Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection SUMMARY: E:\FR\FM\03MRN1.SGM 03MRN1

Agencies

[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12483-12484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0008]


Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces a

[[Page 12484]]

forthcoming public advisory committee meeting of the Circulatory System 
Devices Panel of the Medical Devices Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public.

DATES: The meeting will take place virtually on April 6, 2021, from 9 
a.m. Eastern Time to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing platform. Answers to 
commonly asked questions including information regarding special 
accommodations due to a disability may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.

FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 
[email protected], 301-796-0400, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before the 
meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On April 6, 
2021, the committee will discuss, make recommendations, and vote on 
information regarding the premarket approval application for the 
TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc. The 
proposed Indication for Use for the TransMedics OCS Heart, is as 
follows: The TransMedics Organ Care System (OCS) Heart System is a 
portable extracorporeal heart perfusion and monitoring system indicated 
for the resuscitation, preservation, and assessment of donor hearts in 
a near-physiologic, normothermic, and beating state intended for a 
potential transplant recipient.
    OCS Heart is indicated for donor hearts with one or more of the 
following characteristics:

 Expected cross-clamp or ischemic time >=4 hours due to donor 
or recipient characteristics (e.g., donor- recipient geographical 
distance, expected recipient surgical time); or
     Expected total cross-clamp time of >=2 hours PLUS one of 
the following risk factors:
     Donor Age >=55 years; or
     Donors with history of cardiac arrest and downtime >=20 
minutes; or
     Donor history of alcoholism; or
     Donor history of diabetes; or
     Donor Left Ventricular Ejection Fraction <=50 percent but 
>=40 percent; or
     Donor history of Left Ventricular Hypertrophy (septal or 
posterior wall thickness of >12 and <=16 mm); or
     Donor angiogram with luminal irregularities but no 
significant coronary artery disease.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting, and the background material 
will be posted on FDA's website after the meeting. Background material 
and the link to the online teleconference meeting room will be 
available at https://www.fda.gov/advisory-committees/circulatory-system-devices-panel/2021-meeting-materials-circulatory-system-devices-panel. Select the link for the 2021 Meeting Materials. The meeting will 
include slide presentations with audio components to allow the 
presentation of materials in a manner that most closely resembles an 
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
March 30, 2021. Oral presentations from the public will be scheduled on 
April 6, 2021, between approximately 1 p.m. Eastern Time and 2 p.m. 
Eastern Time. Those individuals interested in making formal oral 
presentations should notify the contact person (see FOR FURTHER 
INFORMATION CONTACT). The notification should include a brief statement 
of the general nature of the evidence or arguments they wish to 
present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before March 22, 2021. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by March 23, 
2021.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Artair Mallet at [email protected] or 301-796-9638 at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during 
advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04371 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P

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